Pharmacokinetic Study With Colchicine in Healthy Volunteers

This study has been completed.

Sponsor:

Information provided by:

Mutual Pharmaceutical Company, Inc.

ClinicalTrials.gov Identifier:

NCT01017003

First received: August 13, 2009

Last updated: October 5, 2009

Last verified: October 2009

History of Changes

Results First Received: August 13, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Pharmacokinetics
Intervention:	Drug: colchicine tablets

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Colchicine - Single Dose, Twice Daily Dose, Final Single Dose	All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.

Participant Flow for 4 periods

Period 1: Single Dose Colchicine 0.6 mg, Day 1

	Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Period 2: 14 Day Washout Period

	Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Period 3: Colchicine 0.6 mg Twice Daily x 10 Days

	Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Period 4: Colchicine 0.6 mg Final Dose

	Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
STARTED	13
COMPLETED	13
NOT COMPLETED	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Colchicine - Single Dose, Twice Daily Dose, Final Single Dose	All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.

Baseline Measures

	Colchicine - Single Dose, Twice Daily Dose, Final Single Dose
Number of Participants [units: participants]	13
Age [units: participants]
<=18 years	0
Between 18 and 65 years	13
>=65 years	0
Age [units: years] Mean ( Full Range )	25.5 ( 19 to 38 )
Gender [units: participants]
Female	1
Male	12
Region of Enrollment [units: participants]
United States	13

Outcome Measures

Show All Outcome Measures

1. Primary:

Maximum Serum Concentration (Cmax) [ Time Frame: Pharmacokinetic samples collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing ]

Show Outcome Measure 1

2. Primary:

Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level. [ Time Frame: 0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing ]

Hide Outcome Measure 2

Measure Type	Primary
Measure Title	Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.
Measure Description	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (t), calculated using the linear trapezoidal rule.
Time Frame	0.0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 36, 48, 72, and 96 hours after dosing
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
by protocol

Reporting Groups

	Description
Colchicine Pharmacokinetics (Day 1)	0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
Colchicine Pharmacokinetics at Steady State (Day 25)	0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)

Measured Values

	Colchicine Pharmacokinetics (Day 1)	Colchicine Pharmacokinetics at Steady State (Day 25)
Number of Participants Analyzed [units: participants]	13	13
Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level. [units: pg-h/ml] Mean ± Standard Deviation	10494.66 ± 3544.08	43576.96 ± 9333.26

No statistical analysis provided for Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level.

3. Primary:

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf) [ Time Frame: 0.0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
14 subjects were sought, 13 enrolled due difficult recruitment. It was impossible to determine the kinetics of metabolites because none reached the level of detectability.

Results Point of Contact:

Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com

No publications provided

Responsible Party:	Vice President Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT01017003 History of Changes
Other Study ID Numbers:	MPC-004-07-1004
Study First Received:	August 13, 2009
Results First Received:	August 13, 2009
Last Updated:	October 5, 2009
Health Authority:	United States: Food and Drug Administration

To Top